A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
Recruiting now · Phase 3
Conditions studied: Crohn's Disease (CD)
In brief
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
Key facts
- Study ID
- NCT04779320
- Run by
- Takeda
- People needed
- 120
- Starts
- 2022-02-10
- Expected to finish
- 2027-09-13
- Last updated by the study team
- 2026-05-05
Who can join
Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Japanese Red Cross Kumamoto Hospital — Kumamoto, Kumamoto, Japan (enrolling)
- Korczowski Bartosz, Gabinet Lekarski — Rzeszów, Podkarpackie Voivodeship, Poland (enrolling)
- Ippokratio General Hospital of Thessaloniki — Thessaloniki, Greece (enrolling)
- Kurume University Hospital — Kurume-Shi, Hukuoka, Japan (enrolling)
- National Center for Child Health and Development — Setagaya-Ku, Tokyo, Japan (enrolling)
- Instytut Pomnik Centrum Zdrowia Dziecka — Warsaw, Masovian Voivodeship, Poland (enrolling)
- University Hospital Center Zagreb — Zagreb, City of Zagreb, Croatia (enrolling)
- Children's Hospital "Agia Sofia" — Athens, Greece (enrolling)
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont — Szeged, Csongrád megye, Hungary (enrolling)
- Sapienza University of Rome — Rome, Lazio, Italy (enrolling)
- Juntendo University Hospital — Bunkyo-Ku, Tokyo, Japan (enrolling)
- Goryeb Children's Hospital — Morristown, New Jersey, United States (enrolling)
- The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS — New Hyde Park, New York, United States (enrolling)
- Advocate Children's Hospital Park Ridge — Park Ridge, Illinois, United States (enrolling)
- Stony Brook University Medical Center — Stony Brook, New York, United States (enrolling)
- Klinika Za Djecje Bolesti Zagreb — Zagreb, City of Zagreb, Croatia (enrolling)
- University Hospital Centre Split — Split, Croatia (enrolling)
- Attikon University General Hospital — Athens, Attica, Greece (enrolling)
- Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz — Miskolc, Borsod-Abauj Zemplen county, Hungary (enrolling)
- Texas Children's Hospital — Houston, Texas, United States (enrolling)
- Carilion Children's Tanglewood Center — Roanoke, Virginia, United States (enrolling)
- MNGI Digestive Health, PA — Minneapolis, Minnesota, United States (enrolling)
- Queensland Childrens Hospital — South Brisbane, Queensland, Australia (enrolling)
- Childrens Center For Digestive Healthcare — Atlanta, Georgia, United States (enrolling)
- Twoja Przychodnia SCM — Szczecin, West Pomeranian Voivodeship, Poland (enrolling)
Full record on ClinicalTrials.gov
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